CIPRALEX 5MG FILM COATED TABLETS

Transcript

GB-623914
Package leaflet: Information for the user

10 mg film-coated tablets
20 mg film-coated tablets

escitalopram
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on
to others. It may harm them, even if their signs of illness are the
same as yours.
• If you get any side effects, talk to your doctor or pharmacist.
This includes any possible side effects not listed in this leaflet.
See section 4.
What is in this leaflet:
1. What Cipralex is and what it is used for
2. What you need to know before you take Cipralex
3. How to take Cipralex
4. Possible side effects
5. How to store Cipralex
6. Contents of the pack and other information
1. What Cipralex is and what it is used for
Cipralex contains the active substance escitalopram. Cipralex belongs to
a group of antidepressants called selective serotonin reuptake inhibitors
(SSRIs). These medicines act on the serotonin-system in the brain by
increasing the serotonin level. Disturbances in the serotonin-system are
considered an important factor in the development of depression and
related diseases.
Cipralex contains escitalopram and is used to treat depression (major
depressive episodes) and anxiety disorders (such as panic disorder with
or without agoraphobia, social anxiety disorder, generalised anxiety
disorder and obsessive-compulsive disorder).
It may take a couple of weeks before you start to feel better. Continue to
take Cipralex, even if it takes some time before you feel any improvement
in your condition.
You must talk to a doctor if you do not feel better of if you feel worse.
2. What you need to know before you take Cipralex
Do not take Cipralex
• If you are allergic to escitalopram or any of the other ingredients of this
medicine (listed in section 6).
• If you take other medicines which belong to a group called MAO inhibitors,
including selegiline (used in the treatment of Parkinson’s disease),
moclobemide (used in the treatment of depression) and linezolid
(an antibiotic).
• If you are born with or have had an episode of abnormal heart rhythm
(seen at ECG; an examination to evaluate how the heart is functioning).
• If you take medicines for heart rhythm problems or that may affect the
heart’s rhythm (see section 2 “Other medicines and Cipralex”).

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Warnings and precautions
Talk to your doctor or pharmacist before taking Cipralex. Please tell your
doctor if you have any other condition or illness, as your doctor may need
to take this into consideration. In particular, tell your doctor:
• If you have epilepsy. Treatment with Cipralex should be stopped if
seizures occur for the first time, or if there is an increase in the seizure
frequency (see also section 4 “Possible side effects”).
• If you suffer from impaired liver or kidney function. Your doctor may
need to adjust your dosage.
• If you have diabetes. Treatment with Cipralex may alter glycaemic control.
Insulin and/or oral hypoglycaemic dosage may need to be adjusted.
• If you have a decreased level of sodium in the blood.
• If you have a tendency to easily develop bleedings or bruises.
• If you are receiving electroconvulsive treatment.
• If you have coronary heart disease.
• If you suffer or have suffered from heart problems or have recently had
a heart attack.
• If you have a low resting heart-rate and/or you know that you may have
salt depletion as a result of prolonged severe diarrhoea and vomiting
(being sick) or usage of diuretics (water tablets).
• If you experience a fast or irregular heart beat, fainting, collapse or
dizziness on standing up, which may indicate abnormal functioning
of the heart rate.
• If you have or have previously had eye problems, such as certain kinds
of glaucoma (increased pressure in the eye).
Please note

Some patients with manic-depressive illness may enter into a manic phase.
This is characterized by unusual and rapidly changing ideas, inappropriate
happiness and excessive physical activity. If you experience this, contact
your doctor.
Symptoms such as restlessness or difficulty in sitting or standing still
can also occur during the first weeks of the treatment. Tell your doctor
immediately if you experience these symptoms.
Thoughts of suicide and worsening of your depression or anxiety disorder
If you are depressed and/or have anxiety disorders you can sometimes
have thoughts of harming or killing yourself. These may be increased
when first starting antidepressants, since these medicines all take time
to work, usually about two weeks but sometimes longer.
You may be more likely to think like this:
• If you have previously had thoughts about killing or harming yourself.
• If you are a young adult. Information from clinical trials has shown an
increased risk of suicidal behaviour in adults aged less than 25 years with
psychiatric conditions who were treated with an antidepressant.

Other medicines and Cipralex
Tell your doctor or pharmacist if you are taking, have recently taken or
might take any other medicines.
Tell your doctor if you are taking any of the following medicines:
• “Non-selective monoamine oxidase inhibitors (MAOIs)”, containing
phenelzine, iproniazid, isocarboxazid, nialamide, and tranylcypromine
as active ingredients. If you have taken any of these medicines you will
need to wait 14 days before you start taking Cipralex. After stopping
Cipralex you must allow 7 days before taking any of these medicines.
• “Reversible, selective MAO-A inhibitors”, containing moclobemide
(used to treat depression).
• “Irreversible MAO-B inhibitors”, containing selegiline (used to treat
Parkinson’s disease). These increase the risk of side effects.
• The antibiotic linezolid.
• Lithium (used in the treatment of manic-depressive disorder) and
tryptophan.
• Imipramine and desipramine (both used to treat depression).
• Sumatriptan and similar medicines (used to treat migraine) and tramadol
(used against severe pain). These increase the risk of side effects.
• Cimetidine, lansoprazole and omeprazole (used to treat stomach ulcers),
fluvoxamine (antidepressant) and ticlopidine (used to reduce the risk
of stroke). These may cause increased blood levels of escitalopram.
• St. John's Wort (hypericum perforatum) - a herbal remedy used for
depression.
• Acetylsalicylic acid (aspirin) and non-steroidal anti-inflammatory
drugs (medicines used for pain relief or to thin the blood, so called anti coagulant). These may increase bleeding-tendency.
• Warfarin, dipyridamole, and phenprocoumon (medicines used to thin
the blood, so called anti-coagulant). Your doctor will probably check the
coagulation time of your blood when starting and discontinuing
Cipralex in order to verify that your dose of anti-coagulant is still adequate.
• Mefloquine (used to treat Malaria), bupropion (used to treat depression)
and tramadol (used to treat severe pain) due to a possible risk of a
lowered threshold for seizures.
• Neuroleptics (medicines to treat schizophrenia, psychosis) and
antidepressants (tricyclic antidepressants and SSRIs) due to a possible
risk of a lowered threshold for seizures.
• Flecainide, propafenone, and metoprolol (used in cardiovascular diseases)
clomipramine, and nortriptyline (antidepressants) and risperidone,
thioridazine, and haloperidol (antipsychotics). The dosage of Cipralex
may need to be adjusted.
• Medicines that decrease blood levels of potassium or magnesium,
as these conditions increase the risk of life-threatening heart rhythm
disorders.
Do not take Cipralex if you take medicines for heart rhythm problems
or medicines that may affect the heart’s rhythm, such as Class IA and
III antiarrhythmics, antipsychotics (e.g. phenothiazine derivatives,
pimozide, haloperidol), tricyclic antidepressants, certain antimicrobial
agents (e.g. sparfloxacin, moxifloxacin, erythromycin IV, pentamidine,
anti-malarial treatment particularly halofantrine), certain antihistamines
(e.g. astemizole, mizolastine). If you have any further questions about
this you should speak to your doctor.
Cipralex with food, drink and alcohol
Cipralex can be taken with or without food (see section 3 “How to take
Cipralex”).
As with many medicines, combining Cipralex with alcohol is not advisable,
although Cipralex is not expected to interact with alcohol.
Pregnancy, breast-feeding and fertility
Inform your doctor if you are pregnant or planning to become pregnant.
Do not take Cipralex if you are pregnant or breast-feeding, unless you and
your doctor have discussed the risks and benefits involved.
If you take Cipralex during the last 3 months of your pregnancy you should
be aware that the following effects may be seen in your newborn baby:
trouble with breathing, bluish skin, fits, body temperature changes,
feeding difficulties, vomiting, low blood sugar, stiff or floppy muscles,
vivid reflexes, tremor, jitteriness, irritability, lethargy, constant crying,
sleepiness and sleeping difficulties. If your newborn baby has any of
these symptoms, please contact your doctor immediately.
Make sure your midwife and/or doctor know you are on Cipralex. When
taken during pregnancy, particularly in the last 3 months of pregnancy,
medicines like Cipralex may increase the risk of a serious condition in
babies, called persistent pulmonary hypertension of the newborn (PPHN),
making the baby breathe faster and appear bluish. These symptoms
usually begin during the first 24 hours after the baby is born. If this happens
to your baby you should contact your midwife and/or doctor immediately.
If used during pregnancy Cipralex should never be stopped abruptly.
It is expected that Cipralex will be excreted into breast milk.
Citalopram, a medicine like escitalopram, has been shown to reduce the
quality of sperm in animal studies. Theoretically, this could affect fertility,
but impact on human fertility has not been observed as yet.
Driving and using machines
You are advised not to drive a car or operate machinery until you know
how Cipralex affects you.
3. How to take Cipralex
Always take this medicine exactly as your doctor has told you. Check with
your doctor or pharmacist if you are not sure.
Adults
Depression
The normally recommended dose of Cipralex is 10 mg taken as one daily dose.
The dose may be increased by your doctor to a maximum of 20 mg per day.
Panic disorder
The starting dose of Cipralex is 5 mg as one daily dose for the first week
before increasing the dose to 10 mg per day. The dose may be further
increased by your doctor to a maximum of 20 mg per day.
Social anxiety disorder
The normally recommended dose of Cipralex is 10 mg taken as one daily dose.
Your doctor can either decrease your dose to 5 mg per day or increase the
dose to a maximum of 20 mg per day, depending on how you respond to
the medicine.

If you have thoughts of harming or killing yourself at any time, contact
your doctor or go to a hospital straight away.

Generalised anxiety disorder
The normally recommended dose of Cipralex is 10 mg taken as one daily
dose. The dose may be increased by your doctor to a maximum of 20 mg
per day.

You may find it helpful to tell a relative or close friend that you are
depressed or have an anxiety disorder, and ask them to read this leaflet.
You might ask them to tell you if they think your depression or anxiety is
getting worse, or if they are worried about changes in your behaviour.

Obsessive-compulsive disorder
The normally recommended dose of Cipralex is 10 mg taken as one daily
dose. The dose may be increased by your doctor to a maximum of 20 mg
per day.

Children and adolescents under 18 years of age
Cipralex should normally not be used for children and adolescents under
18 years. Also, you should know that patients under 18 have an increased
risk of side effects such as suicide attempts, suicidal thoughts and hostility
(predominately aggression, oppositional behaviour and anger) when they
take this class of medicines. Despite this, your doctor may prescribe
Cipralex for patients under 18 because he/she decides that this is in their
best interest. If your doctor has prescribed Cipralex for a patient under 18
and you want to discuss this, please go back to your doctor. You should
inform your doctor if any symptoms listed above develop or worsen when
patients under 18 are taking Cipralex. Also, the long term safety effects
concerning growth, maturation and cognitive and behavioural development
of Cipralex in this age group have not yet been demonstrated.

Elderly patients (above 65 years of age)
The recommended starting dose of Cipralex is 5 mg taken as one daily dose.
The dose may be increased by your doctor to 10 mg per day.
Children and adolescents (below 18 years of age)
Cipralex should not normally be given to children and adolescents.
For further information please see section 2 “What you need to know
before you take Cipralex”.
You can take Cipralex with or without food. Swallow the tablet with some
water. Do not chew them, as the taste is bitter.

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5 mg film-coated tablets

GB-623914

Duration of treatment
It may take a couple of weeks before you start to feel better. Continue to
take Cipralex even if it takes some time before you feel any improvement
in your condition.
Do not change the dose of your medicine without talking to your doctor first.
Continue to take Cipralex for as long as your doctor recommends. If you stop
your treatment too soon, your symptoms may return. It is recommended that
treatment should be continued for at least 6 months after you feel well again.
If you take more Cipralex than you should
If you take more than the prescribed dose of Cipralex, contact your doctor
or nearest hospital emergency department immediately. Do this even if
there are no signs of discomfort. Some of the signs of an overdose could
be dizziness, tremor, agitation, convulsion, coma, nausea, vomiting,
change in heart rhythm, decreased blood pressure and change in body
fluid/salt balance. Take the Cipralex box/container with you when you go
to the doctor or hospital.
If you forget to take Cipralex
Do not take a double dose to make up for forgotten doses. If you do forget
to take a dose, and you remember before you go to bed, take it straight away.
Carry on as usual the next day. If you only remember during the night, or
the next day, leave out the missed dose and carry on as usual.
If you stop taking Cipralex
Do not stop taking Cipralex until your doctor tells you to do so. When you
have completed your course of treatment, it is generally advised that the
dose of Cipralex is gradually reduced over a number of weeks.
When you stop taking Cipralex, especially if it is abruptly, you may feel
discontinuation symptoms. These are common when treatment with
Cipralex is stopped. The risk is higher, when Cipralex has been used for
a long time or in high doses or when the dose is reduced too quickly.
Most people find that the symptoms are mild and go away on their own
within two weeks. However, in some patients they may be severe in
intensity or they may be prolonged (2-3 months or more). If you get severe
discontinuation symptoms when you stop taking Cipralex, please contact
your doctor. He or she may ask you to start taking your tablets again and
come off them more slowly.
Discontinuation symptoms include: Feeling dizzy (unsteady or off-balance),
feelings like pins and needles, burning sensations and (less commonly)
electric shock sensations, including in the head, sleep disturbances (vivid
dreams, nightmares, inability to sleep), feeling anxious, headaches,
feeling sick (nausea), sweating (including night sweats), feeling restless
or agitated, tremor (shakiness), feeling confused or disorientated, feeling
emotional or irritable, diarrhoea (loose stools), visual disturbances,
fluttering or pounding heartbeat (palpitations).
If you have any further questions on the use of this product, ask your
doctor or pharmacist.

• Sudden swelling of skin or mucosa (angioedemas)
• Increase in the amount of urine excreted (inappropriate ADH secretion)
• Flow of milk in men and in women that are not nursing
• Mania
• An increased risk of bone fractures has been observed in patients taking
this type of medicine
• Alteration of the heart rhythm (called “prolongation of QT interval”,
seen on ECG, measuring electrical activity of the heart).
In addition, a number of side effects are known to occur with drugs that
work in a similar way to escitalopram (the active ingredient of Cipralex).
These are:
• Motor restlessness (akathisia)
• Loss of appetite
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet. You can also
report side effects directly (see details below).
By reporting side effects you can help provide more information on the
safety of this medicine.
United Kingdom
Via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Alternatively you can call Freephone 0808 100 3352 (available between
10am-2pm Monday – Friday) or fill in a paper form available from your
local pharmacy.
Malta
ADR Reporting
The Medicines Authority
Post-Licensing Directorate
203 Level 3, Rue D'Argens
GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
5. How to store Cipralex
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the label
or carton after EXP. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not throw away any medicines via wastewater or household waste.
Ask your pharmacist how to throw away any medicines you no longer use.
These measures will help to protect the environment.
6. Contents of the pack and other information
What Cipralex contains
The active substance is escitalopram. Each Cipralex tablet contains 5 mg,
10 mg or 20 mg escitalopram (as oxalate).
The other ingredients are:
Core: microcrystalline cellulose, colloidal anhydrous silica, talc,
croscarmellose sodium and magnesium stearate.
Coating: hypromellose, macrogol 400 and titanium dioxide (E171).

4. Possible side effects

What Cipralex looks like and contents of the pack
Cipralex is presented as 5 mg, 10 mg and 20 mg film-coated tablets.
The tablets are described below.

Like all medicines, this medicine can cause side effects, although not
everybody gets them.

The side effects usually disappear after a few weeks of treatment.
Please be aware that many of the effects may also be symptoms of your
illness and therefore will improve when you start to get better.

10 mg: Oval, white film-coated tablets. The tablets are scored and
marked with “E” and “L” on each side of the score on one side
of the tablet.

If you experience any of the following symptoms you should contact
your doctor or go to the hospital straight away:

20 mg: Oval, white film-coated tablets. The tablets are scored and
marked with “E” and “N” on each side of the score on one side
of the tablet.

Uncommon (may affect up to 1 in 100 people):
• Unusual bleeds, including gastrointestinal bleeds
Rare (may affect up to 1 in 1000 people):
• Swelling of skin, tongue, lips, or face, or have difficulties breathing or
swallowing (allergic reaction).
• High fever, agitation, confusion, trembling and abrupt contractions
of muscles these may be signs of a rare condition called serotonin
syndrome.
Not known (frequency cannot be estimated from the available data):
• Difficulties urinating
• Seizures (fits), see also section 2 “Warnings and precautions”
• Yellowing of the skin and the white in the eyes are signs of liver function
impairment/hepatitis
• Fast, irregular heart beat, fainting which could be symptoms of a
life-threatening condition known as torsade de pointes
• Thoughts of harming or killing yourself, see also section 2 "Warnings
and precautions"

If necessary, you can divide the tablets by firstly placing the tablet
on a flat surface with the score facing upwards. The tablets may then
be broken by pressing down on each end of the tablet, using both
forefingers as shown in the drawing.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.